Dispensing method and apparatus

ABSTRACT

A fluid dispensing instrument and method for introducing a fluid, as drug materials, into the canals of the Fallopian tubes of a primate female. The dispensing instrument has a tubular probe carrying an expandable balloon assembly. A stop collar on the probe positions the balloon assembly in the uterine cavity. The balloon assembly has a sleeve member which is initially expanded to close the lower portion of the uterine cavity. The drug material is introduced through the probe into the upper portion of the uterine cavity above the expanded balloon assembly. The balloon assembly is then further expanded to force the drug material from the upper portion of the uterine cavity into the canals of the Fallopian tubes. The expanding balloon assembly divides the material and forces the drug material into both of the canals.

United States Patent 1191 Bolduc I I [73] Assignee: Population ResearchIncorporated,

Minneapolis, Minn. [22] Filed: June 25, 1973 [21] Appl. No.: 372,971

[52] U.S. Cl 128/235, 128/260, 128/130, 128/1 R, 128/349 B [51] Int. ClA6lm l/00 [58] Field of Search 128/235, 234, 232, 224,

References Cited UNITED STATES PATENTS 2,696,212 12/1954 Dunmire128/216. 2,699,167 1/1955 Raiche'. 128/216 2,854,982 10/1958 Pagano,128/349 BU 3,042,030 7/1962 Read 128/127- 3,211,151 10/1965 Foderick etal.... 128/349 B 3,394,705 7/1968 Abramson 128/349 B 3,401,689 9/1968Greenwood 128/129 3,422,813 1/1969' Braley et a1 128/1.

1 probe into the upper portion of the uterine cavity above the expandedballoon assembly. The balloon as- 111] 9 3,822,702 [451 i July 9, 19747/1969 Riedell..... 2.;128/129 3,452,749 3,459,175 8/1969 Miller 128/349B 3,680,542 8/1972 Cimber 128/1 R Primary Examiner-Richard A. GaudetAssistant ExaminerJ. Yasko [57] ABSTRACT expanded to close the lowerportion of the uterine cavity. The drug material is introduced throughthe sembly is thenfurther expanded to force the drug material from theupper portion of the uterine cavity into the canals of the Fallopiantubes. The expanding balloon assembly divides the material and forcesthe drug material into both of the canals.

13 Claims, 3 Drawing Figures 1 DISPENSING METHOD AND APPARATUSBACKGROUND OF INVENTION Bilateral disection of Fallopian tubes is acommon surgical procedure used to sterilize a female primate. Thisprocedure involves severing and tying the Fallopian tubes. Intrauterinedevices, as plugs and wires, are used to temporarily sterilize a female.These devices include plugs which are inserted into the canals of theFallopian tubes to prevent ova from passing the canals into the uterus.Smith in 1849 described a method to treat sterilityby passing whale bonesplints into the canals. These devices do not insure that theova cannotflow through the canals into the uterus. The devices can be dislodgedand lost without the female being aware of it. There is no assurancethat the devices are effective. Climer in U.S. Pat. No. 3,675,693 andNo. 3,680,245 discloses plugs attached to the uterine wall to block theentrance of ova into the uterus from the Fallopian canals and the exitof sperm from the uterine cavity into the Fallopian canal. These plugsare designed to effect temporary sterilization in that they can beremoved and do not permanently block the canals of the Fallopian tubes.Plug contraceptive devices are not entirely effective in that it ispossible for ova to bypass the plugs and enter the uterus.

Liquid tissue adhesives have been developed which polymerize whenapplied to moist living tissue. These adhesives have been used forvarious surgical procedures. When the tissue adhesives are used, thecells adjacent the tissue are damaged and eventually replaced with afibrous tissue. A liquid tissue adhesive has been injected into theuterine cavity with a catheter to occlude the canals of the Fallopiantubes. Studies have been conducted into silver nitrate, zinc chlorideand methyl cyanoacrylate to occlude the canals of the Fallopian tubes.These materials have been introduced into the uterine cavity withballoon catheters in an effort to place the materials in the canals of,the Fallopian tubes. These catheters are not designed to accommodate thedifferent sizes, shapes and characteristics of the uteri and do notinsure that the materials areplaced in each canal of the Fallopiantubes. Also, these catheters may direct all the material into one canalso that the material is forced through this canal into the body cavity.

SUMMARY OF INVENTION position the balloon assembly in the uterine cavitywith the forward end of the balloon assembly spaced from the top wall orfundus of the uterus. A dispenser operates to initially expand theballoon assembly to displace the lower portion of the uterine cavity andform a low pressure seal with the inner wall of the lower part of theuterus. The balloon assembly can be fully expanded to sense the size ofthe uterine cavity. The balloon assembly is partially contracted tomaintain a low pressure seal with the inner wall of the lower part ofthe uterus.

The dispenser is then again actuated to discharge a drug material, as atissue adhesive, into the uterine cavity above the balloon assembly. Theballoon assembly is then further expanded to displace the remainingspace of the uterine cavity. The balloon assembly expands and initiallyengages the midportion of the fundus and thereby divides the drugmaterial into separate portions. The further expansion of the balloonassembly forces the separate portions of the drug material into theseparate canals of the Fallopian tubes. Substantially all of the drugmaterialintroduced into the uterine cavity is moved into the canals ofthe Fallopian tubes on expansion of the balloon assembly. When a tissueadhesive is placed into the canals it reacts with the moisture in thetissue of the Fallopian tubes to polymerize the adhesive and therebyocclude the canals. The tissue adhesive is eventually replaced with scartissue which permanently occludes the canals. A flushing fluid, aswater, can be introduced into the uterine cavity before the balloonassembly is removed from the cavity. The balloon assembly is contractedwhereby it can be readily removed from the uterine cavity.

An object of the invention is to provide an apparatus and method ofintroducing a predetermined minimum amount of drug materials into bothcanals of the Fallopian tubes of a primate female from the uterinecavity. Another object of the invention is to provide a method andapparatus for introducing a controlled amount of drug material into thecanals of the Fallopian tubes under low pressure, whereby the drugmaterial does not flow through the Fallopian tubes into the body cavity.A further object of the invention is to provide a method and apparatusfor introducing drug materials into the canals of the Fallopian tubeswhich places a minimum amount of force on the walls of the uterus andwhich can accommodate different sizes, shapes and characteristics ofuteri. Yet another object of the invention is to provide a method andapparatus for introducing a fluid material into both canals of theFallopian tubes which is not position sensitive and does not applysubstantial pressures to the fluid material whereby the fluid materialis not forced into the blood stream.

IN THE DRAWINGS FIG. 1 is a sectional view of the reproductive system ofa primate female accommodating a dispensing instrument to practice themethod of the invention of locating drug material in both canals of theFallopian tubes;

FIG. 2 is a sectional view of the uterus of FIG. 1 showing the balloonin an expanded position to divide the uterine cavity;

FIG. 3 is a sectional view similar to FIG. 2 showing the balloon in thefull expanded position forcing the drug material into both canals of theFallopian tubes.

Referring to the drawings, as shown in FIG. 1, a dispensing instrumentindicated generally at 20 in operative relation with the femalereproductive system indicated generally at 21 of a primate female.System 21 has a uterus 22 and a pair of Fallopian tubes 23 and 24. Thelower part of uterus 22 is integral with an elongate vagina 26. Thevagina 26 has a vaginal cavity 27 having an opening or entrance 28. Theopposite end of the cavity 27 is in communication with the cervix 31having a cervical opening providing a passage from the vaginal cavity 27into the uterine cavity 32. The Fallopian tubes 23 and 24 each have acanal or aqueduct 33 and 34 respectively, which open or exit to theupper part of the uterine cavity 32.

Uterus 22 is a generally pear-shaped, thick-walled, hollow organsituated between the bladder and rectum. The uteri of primate femalesvary in size and shape. The wall thicknesses, strength and sensitivityto pain vary from female to female. The inner wall of the uterus maycontain lymph nodes and vary in size and configuation. The uterinecavities of the uteri vary in size and shape. Some uteri have strongwalls while others have Weak and realtively elastic walls. Generally,the uterine cavity 32 is flattened and triangular in shape.

The Fallopian tubes 23 and 24 are paired, trumpetshaped, muscular linearmembers which extend from the superior angles of the uterine cavity tothe ovaries (not shown). The Fallopian tubes of an adult female aremusculo-membranous structures about l2 cm. in length. The outlet of thecanals of the Fallopian tubes can vary in position relative to theuterine cavity 32. Also, the size of the canals 33 and 34 vary fromfemale to female. The Fallopian tubes are commonly divided into isthmus,intramural and ampullary sections. The canals 33 and 34 provide passagesfor movement of ova from the ovaries into the uterine cavity 32. Theintramural sections of the Fallopian tubes traverse the uterine wall inmore or less straight fashion. It has an ampullalike dilation justbefore it communicates with the uterine cavity 32. The walls of theFallopian tubes con sist of three layers; the serosal layer, themuscular layer, and the mucosa] lining. The muscular layer includeslongitudinal muscle fibers which, when contracted, bring the outer endsof the Fallopian tubes into close contact with the surfaces of theovaries. Blood vessels are abundant in the muscular layer where theyform with the muscle bundles a kind of erectile tissue which, ifengorged with blood, move the Fallopian tubes to sweep over the surfacesof the ovaries. This movement of the Fallopian tubes is impaired whenthe tubes are severed and tied. The occluding of the canals 33 and 34with drug material according to the invention does not interfere withthe erectile action and movement of the Fallopian tubes relative to theovaries.

The uterus 21 has a top wall or fundus 36 and side walls 37 and 38surrounding the uterine cavity 32. The inside of the top wall 36 and theside walls 37 and 38 have an inside lining or membrane 39 whichperiodically is sloughed off in the normal cycle of the female.

The dispensing instrument 20 has an elongated probe or tubular support41 of a length to pass through the vaginal cavity 27 and into theuterine cavity 32. The longitudinal position of the probe 41 relative tothe uterine cavity 32 is determined by an annular stop member or collar42 The collar 42 is secured to the probe 41 adjacent the inner end of anexpandable balloon assembly indicated generally at 43.

Balloon assembly 43 has a sleeve member or tubular membrane 44. Theupper or outer end of the member 44 is secured to the support 41 with anannular fastener as a collar or threads 46. A similar annular fastener47 secures the inner end of the sleeve member 44 to the probe 4]. Theprobe 41 has a plurality of openings 45 to provide for communication offluid from within the probe 41 to the chamber 69 surrounded by thesleeve member 44.

The sleeve member 44 is a tubular sheet member of soft and relaxedflexible and elastic material, as rubber or plastic, which expands witha minimum of elongation of the material. For example, thin latex rubberhaving low surface tension, whereby the rubber uniformly expands with arelatively low pressure, is suitable material for sleeve member 44. Thematerial of sleeve member 44 readily expands to displace the uterinecavity 32 by conforming to the shape of the cavity without applyingextreme pressure to localized portions of the uterus. When the cavity 32is partially displaced and fully displaced with the expanded sleevemember 44, as shown in FIGS. 1, 2 and 3, the member 44 is in uniformsurface engagement with the inside wall 39. Conventional ballooncathethers, being of hard, relatively non-elastic material, do notassume the configuration of the uterine cavity when expanded under lowpressure.

A dispenser indicated generally at 48 is secured to the outside end ofprobe 41. Dispenser 48 has a housing or body 49. A pair of oppositelydirected handles 51 and 52 are secured to the body to serve as fingergrips in the use of the instrument. The housing 49 has chambers foraccommodating containers 53 and 54 connected with passages 56 and 57,respectively. The passages 56 and 57 are open to the passage in theprobe 41. Located between containers 53 and 54 is a third container 58.Container 58 is adapted to be coupled to elongated tube 59 extendedlongitudinally through the probe 41. Tube 59 has an outer or dischargeend 61 at the outer end of the balloon assembly 43. Plungers 62, 63, and64, slideably mounted on the housing 49, are operable to apply forces tothe containers 53, 54 and 58 and thereby discharge the fluids in thecontainers via the probe 41 to the balloon assembly 43 or the uterinecavity 32. Each plunger has a separate lock 66, 67 and 68 respectivelywhich holds the plunger in its inactive position. The locks are manuallyreleased, which enables the plungers 62, 63 and 64 to be moved into thehousing 49 and thereby apply forces to the containers associated withthe plungers.

Dispenser 48 can be constructed in accordance with the dispenser asshown in FIGS. 1 to 10 in pending US. Pat. application Ser. No. 361,418.The disclosure of this application is incorporated herein by reference.Other types of dispensers can be used to provide fluid under pressure tothe balloon assembly 43 and discharge drug materials, tissue adhesivesand the like into the uterine cavity 32.

For example the dispensing apparatus disclosed in pending U.S.applications Ser. No. 339,911 and Ser. No. 361,418 can be used to expandte balloon assembly 43 and discharge drug material into the uterinecavity. The disclosures of these applications are incorporated herein byreference.

The tissue adhesive can be cyanoacrylate, silver nitrate, quinacrinematerial and like material used as surgical glues. The cyanoacrylate isa liquid plastic which sets up or polymerizes in response to moistureand thereby functions to occlude the canals of the Fallopian tubes. Thecyanoacrylates include, but are not limited to, methyl cyanoacrylate,methyl-2-cyanoacrylate, ethyl cyanoacrylates, n-propyl cyanoacrylates,n-butyl cyanoacrylates, n-amyl cyanoacrylates, n-hexl cyanoacrylates,n-heptyl cyanoacrylates, isobutyl-Z- cyanoacrylates and n-octylcyanoacrylates. Quinacrine material is a relatively thick or heavy fluidin the nature of a semi-fluid. The pumping action due to the expansionof the sleeve member 44, hereinafter described, in the uterine cavity 32is effective in moving this material from the uterine cavity into thecanals of the Fallopian tubes. The drugs can be of the type thattemporarily block or occlude the canals of the Fallopian tubes. After aperiod of time, the canals will reopen to resume their normal function.

In use, the dispensing instrument is loaded with the containers 53, 54and 58. The containers can be preloaded prior to the operatingprocedure. With the patient in the reclined position, the collapsedballoon assembly 43 is moved through the vaginal cavity 27 and throughthe cervical opening in to the uterine cavity 32. This located theballoon assembly 43 in the lower part of the uterine cavity 32. Theprobe 41 is moved up into the uterus until the collar 42 is locatedagainst the cervix 31, as shown in FIG. 1. The balloon assembly, beingin a deflated condition, slides readily through the cervical opening andinto the uterine cavity 32. The balloon assembly 43 shown in FIG. 1 ispositioned in the central longitudinal position. This position is notalways achieved in theinsertion procedure. The balloon assembly 43 maybe located on either side and extend at an angle toward one of theFallopian tubes. The method hereinafter described is operable to movedrug materials into both canals regardless of the position of theballoon assembly 43 in the uterine cavity. In other words, to beoperable, the balloon assembly is not position sensitive.

The sleeve member 44 then is expanded by introducing fluid, eitherliquid or air, under pressure into the balloon cavity 69. The sleevemember 44 is partially expanded to till the lower part of the uterinecavity 32 to form a seal with the inner surface 71 of the side walls 37and 38. The top of the balloon assembly 43 is spaced from the inner wallof the fundus 36. The sleeve member 44 is initially expanded byreleasing the lock 66. This permitsthe plunger 62 to move into thehousing 49, forcing the fluid in the container 53 into the balloonchamber 69 via the probe 41. Sleeve member 44 of the balloon assemblybeing of a low tension expandable material, places uniform low pressureon the inner surface 7] of the uterus and assumes the shape of the lowerpart of the uterine cavity without subjecting any specific portion ofthe uterus to substantial pressure.

Balloon assembly 43 can be fully expanded to sense the size of theuterine cavity 32. The balloon assembly 43 is partially reduced in sizeto move it away from the inner wall 73 of the fundus, thereby leaving aspace between the inner wall 73 and the partially expanded balloonassembly 43, as shown in FIG. 1.

Drug material 72 is then dispensed from container 58 by releasing thelock 67. The plunger 63 applies force amount of pressure.

Referring to FIG. 2, the sleeve member 44 is further expanded until itengages the inner wall 73 of the funexpanded by introducing additionalfluid into the balloon chamber 69. The sleeve member 44 expands to fillor displace the portions of the uterine cavity leading to the canals 33and 34 of the Fallopian tubes. The expansion of the sleeve member 44forces the drug materials 720 and 7212 under low pressure into thecanals 33 and 34. In other words, the expanding sleeve member 44functions as a diaphragm pump to force or move the drug materials 72aand 721) into the canals 33 and 34 respectively. The sleeve member 44,being in firm engagement with the inside surface 71 and the inner wall73, prevents the drug materials 72a and 72b from remaining in theuterine cavity 32. As it expands, the sleeve member 44 does not block orhold drug material as it pushes the drug material into the canals of theFallopian tubes.

When drug materials of the tissue adhesive type are used, the canals 33and 34 will be permanently occluded. The tissue adhesives, as thecyonoacrylate type, cause fibroplastic proliferation which in time willhistologically close the canals 33 and 34. The tissue adhesivespolymerize when subjected to moist living tissue. The cells adjacent thetissue are damaged and eventually replaced by fibrous tissue.

The sleeve member 44 then is contracted to about the position shown inFIG. 1. A second fluid, as water, is then injected into the uterinecavity 32 to dilute and wash away any drug material that remains in thecavity 32. The sleeve member 44 is then completely contracted byallowing the fluid in the balloon chamber 69 to drain back into thedispenser 48 or into a reservoir or container attached to the dispenser.When the fluid from chamber 69 has been evacuated, the balloon assemblyis withdrawn from the uterine cavity 32 to conclude the operation.

While there have been shown and described a preferred embodiment of thedispensing instrument and method of introducing drug material into bothcanals of the Fallopian tubes of a primate female, it is understood thatvarious changes in the structure and method may be made by those skilledin the art without departing from the spirit of the invention.

The embodiments of the invention in which an exclusive property orprivilege is claimed are defined as follows:

l. A method of placing material in both canals of F allopian tubes opento the uterine cavity of a uterus with an expandable balloon assemblycomprising: introducing the balloon assembly into the uterine cavity,expanding the balloon assembly into engagement with the inside sidewalls of the uterus and spaced from the inside top wall of the uterus,discharging material into the uterine cavity between the expandedballoon assembly and the inside top wall of the uterus, furtherexpanding the balloon assembly into engagement with the top inside wallof the uterus dividing the material into two portions and forcing oneportion into one canal with one part of the balloon assembly and theother portion into the other canal with the other portion of the balloonassembly, contracting the balloon assembly, and

removing the contracted balloon assembly from the uterine cavity.

2. The method of claim 1 wherein: the balloon assembly is introducedinto the uterine cavity to a selected position with the balloon assemblyspaced from the inside top wall of the uterus.

3. The method of claim 2 wherein: the balloon assembly is held in theselected position during the discharge of material in the uterinecavity.

4. The method of claim 1 wherein: the balloon assembly during thefurther expansion thereof initially engages the central section of theinside top wall of the uterus dividing the uterine cavity into twoparts.

5. The method of claim 1 including: discharging a second material intothe uterine cavity before the balloon assembly is contracted.

6. A method of placing material in both canals of Fallopian tubes opento the uterine cavity with an expand able sleeve member comprising:introducing the sleeve member into the uterine cavity, expanding thesleeve member into engagement with the inside side walls and top wall ofthe uterus to displace the uterine cavity, contracting the expandedsleeve member to move the sleeve member out of engagement with theinside top wall of the uterus, discharging material into the uterinecavity between the contracted sleeve member and the inside top wall ofthe uterus, expanding the sleeve member to displace the uterine cavityby moving the sleeve member into engagement with the inside top wallofthe uterus thereby dividing the material into two portions and forcingone portion into one canal with one part of the sleeve member and theother portion into the other canal with another part of the sleevemember, contracting the sleeve member, and removing the contractedsleeve member from the uterine cavity.

7. The method of claim 6 wherein: the sleeve member is introduced intothe uterine cavity to a selected position spaced from the inside topwall of the uterus.

8. The method of claim 6 wherein: the sleeve mem ber during the secondexpansion thereof to fully displace the uterine cavity initially engagesthe central section of the inside top wall of the uterus dividing theuterine cavity into two parts.

9. The method of claim 6 including: discharging a second material intothe uterine cavity after the first material has been moved into thecanals and before the sleeve member is contracted for removal from theuterine cavity.

10. An apparatus for placing material in both canals of Fallopian tubescomprising: a balloon assembly having an expandable sleeve member,elongated means supporting the balloon assembly, means on the elongatedmeans to position the balloon assembly in the uterine cavity spaced fromthe inside top wall of the uterus, first means operable to expand thesleeve member into engagement with the inside side walls of the uterus,second means for discharging material into the uterine cavity betweenthe expanded sleeve member and the inside top wall of the uterus, saidfirst means being operable to further expand the sleeve member intoengagement with the inside top wall of the uterus whereby the materialis divided into two separate portions, said further expansion of thesleeve member forcing one portion into one canal of one Fallopian tubeand the other portion into the other canal of the other Fallopian tube.

11. The apparatus of claim 101 wherein: the sleeve member is made ofexpandable tubular sheet material having low surface tension properties.

12. The apparatus of claim 11 wherein: the means on the elongated meansis an annular collar.

13. The apparatus of claim 10 wherein: the elongated means is a tubularmember connected to the first means and second means.

1. A method of placing material in both canals of Fallopian tubes opento the uterine cavity of a uterus with an expandable balloon assemblycomprising: introducing the balloon assembly into the uterine cavity,expanding the balloon assembly into engagement with the inside sidewalls of the uterus and spaced from the inside top wall of the uterus,discharging material into the uterine cavity between the expandedballoon assembly and the inside top wall of the uterus, furtherexpanding the balloon assembly into engagement with the top inside wallof the uterus dividing the material into two portions and forcing oneportion into one canal with one part of the balloon assembly and theother portion into the other canal with the other portion of the balloonassembly, contracting the balloon assembly, and removing the contractedballoon assembly from the uterine cavity.
 2. The method of claim 1wherein: the balloon assembly is introduced into the uterine cavity to aselected position with the balloon assembly spaced from the inside topwall of the uterus.
 3. The method of claim 2 wherein: the balloonassembly is held in the selected position during the discharge ofmaterial in the uterine cavity.
 4. The method of claim 1 wherein: theballoon assembly during the further expansion thereof initially engagesthe central section of the inside top wall of the uterus dividing theuterine cavity into two parts.
 5. The method of claim 1 including:discharging a second material into the uterine cavity before the balloonassembly is contracted.
 6. A method of placing material in both canalsof Fallopian tubes open to the uterine cavity with an expandable sleevemember comprising: introducing the sleeve member into the uterinecavity, expanding the sleeve member into engagement with the inside sidewalls and top wall of the uterus to displace the uterine cavity,contracting the expanded sleeve member to move the sleeve member out ofengagement with the inside top wall of the uterus, discharging materialinto the uterine cavity between the contracted sleeve member and theinside top wall of the uterus, expanding the sleeve member to displacethe uterine cavity by moving the sleeve member into engagement with theinside top wall of the uterus thereby dividing the material into twoportions and forcing one portion into one canal with one part of thesleeve member and the other portioN into the other canal with anotherpart of the sleeve member, contracting the sleeve member, and removingthe contracted sleeve member from the uterine cavity.
 7. The method ofclaim 6 wherein: the sleeve member is introduced into the uterine cavityto a selected position spaced from the inside top wall of the uterus. 8.The method of claim 6 wherein: the sleeve member during the secondexpansion thereof to fully displace the uterine cavity initially engagesthe central section of the inside top wall of the uterus dividing theuterine cavity into two parts.
 9. The method of claim 6 including:discharging a second material into the uterine cavity after the firstmaterial has been moved into the canals and before the sleeve member iscontracted for removal from the uterine cavity.
 10. An apparatus forplacing material in both canals of Fallopian tubes comprising: a balloonassembly having an expandable sleeve member, elongated means supportingthe balloon assembly, means on the elongated means to position theballoon assembly in the uterine cavity spaced from the inside top wallof the uterus, first means operable to expand the sleeve member intoengagement with the inside side walls of the uterus, second means fordischarging material into the uterine cavity between the expanded sleevemember and the inside top wall of the uterus, said first means beingoperable to further expand the sleeve member into engagement with theinside top wall of the uterus whereby the material is divided into twoseparate portions, said further expansion of the sleeve member forcingone portion into one canal of one Fallopian tube and the other portioninto the other canal of the other Fallopian tube.
 11. The apparatus ofclaim 10 wherein: the sleeve member is made of expandable tubular sheetmaterial having low surface tension properties.
 12. The apparatus ofclaim 11 wherein: the means on the elongated means is an annular collar.13. The apparatus of claim 10 wherein: the elongated means is a tubularmember connected to the first means and second means.